Reliable profile [Study Assessment]
Hi Helmut!
Nope.
Reference
40
Rep - of the 2 reference arm
His other reference and test arms have more concentration values but still many BLQs. His "meaningful" profiles are lower in magnitude than other subjects and yes there are subjects with comparable "small" values. The questionable part is the reference arm with only 2 datapoints. AUC is defintely smaller than other subject.
From what I understand and being taught (by old schoolers) is never drop a subject... But this one is strange because there are only two points and they are next to each other (I guess, Cmax and post Cmax)...
Thanks
John
❝ • PPI? 
Nope.
❝ • Test or Reference?
Reference
❝ • Sample size?
40
❝ • 2×2 or replicate?
Rep - of the 2 reference arm
His other reference and test arms have more concentration values but still many BLQs. His "meaningful" profiles are lower in magnitude than other subjects and yes there are subjects with comparable "small" values. The questionable part is the reference arm with only 2 datapoints. AUC is defintely smaller than other subject.
From what I understand and being taught (by old schoolers) is never drop a subject... But this one is strange because there are only two points and they are next to each other (I guess, Cmax and post Cmax)...
Thanks
John
Complete thread:
- Question about subject with very few timepoints jag009 2013-04-25 17:45
- Reliable profile Helmut 2013-04-25 18:16
- Reliable profilejag009 2013-04-25 20:19
- Reliable profile ElMaestro 2013-04-25 22:40
- CVintra result of outlier Dr_Dan 2013-04-26 08:58
- Reliable profile ElMaestro 2013-04-25 22:40
- Reliable profilejag009 2013-04-25 20:19
- Reliable profile Helmut 2013-04-25 18:16
